BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P950037 · Supplement: S049 · Decision Mar 26, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    VARIOUS MODELS OF PHILOS/AXIOS/PROTOS/CYLOS PG'S
    PMA Number
    P950037
    Supplement Number
    S049
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 26, 2007
    Date Received
    January 11, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) UPDATES TO THE INTEGRATED CIRCUIT USED FOR ELECTROGRAM SENSING AND NON-RATE RESPONSIVE PACEMAKER TIMING, 2) MODIFICATIONS TO THE ELECTRONIC MODULE, AND 3) IMPLEMENTATION OF MULTI-LINGUAL LABELING.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable